August, 2016

“What Happened with Clinical Trial?”

People have asked me the clinical trials’ status, but it is difficult to explain.

First I sent the consent forms for the vaccine trial about two weeks ago, and am waiting for the next cue.

Second, after some confusion, finally I got the right name of the immune checkpoint inhibitor trial from Cedars Sinai. However, When I looked at the description of the trial, the investigated drugs in the trial,Ibrutinib & MEDI4736 are different from The drug, Keytruda, which I learned from Mrs. E in Germany.

Ibrutinib is a cancer targeted drug, which is already approved for blood cancer like Leukemia by FDA, and MEDI4736 is an investigated PD1 inhibitor drug, which has been studied for non small lung cancer, but it seems like that both are the first time to study with breast cancer.
The side-effects of MEDI4736 seems mild, but Ibrutinib may cause bleeding, plunging platelet count, infection, and even different cancer! Though the trial sounds so scary, Mrs. E, who has been on Keytruda, said the drug gave her back the normal life with almost zero side effects.

A PD1 inhibitor drug works when PD1 expression is high. If my PD1 expression is low, this trial won’t be an option anyway, so I am asking different sources how to check the PD1 expression.

Meanwhile my primary oncologist mentioned about a phase 2 cancer targeted drug clinical study. This investigated drug is designed to respond to certain cancer genes. I asked her to send me the details of this trial.

It must be good to have more than one option, but so far every option seems to have high risk, and I don’t know which one is the best. I have to keep praying for God’s guidance.

Vaccine Responded 50%

“A vaccine therapy has not been successful.”

From my oncologist, the NY Times article, and more different sites, I have heard or read the same message. Dr. Slamon at UCLA didn’t oppose this option, but told me that it may take a long time to see the response.

Uncertainty makes me nervous, and difficult to choose the right trial, yet the vaccine trial has had phase 1 part 1 study inviting 30 participants already. I decided to ask questions directly to the investigating doctor of the vaccine study in order to solve uncertainty.

The reply came right away. Using a war analogy the doctor explained that conventional chemo or radiation therapy is like dropping a bomb, but the vaccine is like training special soldiers how to find and fight the enemy. So the vaccine takes longer than chemo or radiation to respond.

Then she gave me the data:
Out of 10 participants, who received intermediate and high dosages of the vaccine, 5 had clinical responses, which means 50%. Out of 5, one had a complete response, which means cancer was gone 100%. Another one had a partial response with 72% reduction of the tumors, and the other three were stable. Those participants are not breast cancer patients but all of them have HER2 positive cancer. HER2 positive breast cancer participants have been recluted in the study since Mar. in this year, and so far there are only 5 participants. Their data is still immature but three are stable and the other two’s cancer has grown, which was expected based on the mice study, but the densities are getting lighter that can be the sign of cancer dying from the inside of tumors.

Usually if the response rate is 20%, the scientists consider it good, so 50% sounds really good to me, and although it is the early stage, the response rate of breast cancer participants looks like 100%.

CT scans are taken every 8 weeks to observe the response though, the earliest response was observed in the 8th week, and more were observed in the 16th week. This is also helpful.

It was no way possible to gain such fresh information 10 years ago. Now because of Internet it is possible. Being deeply thankful for the doctor who answered throughly and quickly, I forwarded the reply to the primary oncologist.

Changing The Plan

Sometimes when we have a strong feeling, we think God is guiding or talking to us.  Yet, the feeling doesn’t  always go with His Will and if we believe the feeling should guide us, we may make a wrong choice.

I am talking about myself.  My feeling was ( or even “is”) voting for the vaccine trial, but I decided to choose a cancer targeted drug, Entrectinib trial the primary oncologist recommended, as the first, and the vaccine as the second.  The immune checkpoint inhibitor drug trial, I asked about at UCLA, will be the third.

After the NY Times published articles about the checkpoint inhibitor drugs, I saw people started talking about the drugs here and there.  I didn’t know, but former president Carter has shrunken his brain cancer with this inhibitor drug,  Keytruda.  This must be really promising, but the available trial of this kind for me is the phase 1 using different drugs, which made me afraid of the side effects such as autoimmune disorder or different cancer.  So this choice will be for the future.

On the other hand, the targeted drug trial is phase 2, and in phase 1 of this study, the response rate was 75%, which is better than 50% of the vaccine response rate.  In this trial, first I have to have the cancer tissue test, which takes two-three weeks. If there is no match between the DNA and the drug, this trial is not for me and I want to try the vaccine, but even just to have the tissue test, I was told to withdraw the consent forms from the vaccine trial.

This morning, I actually received the confirmation email of my eligibility for the 2nd screening for the vaccine.  It took about a month to get this confirmation, and I was about ready to have the 2nd screening such as CTs and blood tests.  If I am not qualified for the targeted drug and want to pursue the vaccine again, do I have to start all over again?  I am asking about it to NCI.

If I am eligible for the targeted drug, Entrectinib, I have to take the drug as long as it works, but with the vaccine I may be able to put the final period of the cancer battle just after four shots.  Such ideas stir up my feeling, yet I should not let the feeling control over the decision.  75% is better than 50%.  Phase 2 is better than phase 1.  My oncologist recommended it.  I don’t have to travel to Maryland.

Anyway, I am learning that it’s a long process to just get in a clinical trial.  I can be patient because I am on the chemo therapy.  Yet if I were off chemo or knowing cancer is growing, no way I can handle this.  Probably this is another Grace of God.

Progress

Being stuck in between two clinical trial’s systems, I was getting weary.
A week ago I emailed NCI asking if the vaccine study team could keep my information in case I want to pursue the vaccine again – though currently I have to withdraw.

Because there hadn’t been any reply, I also emailed the Kaiser research director asking if holding the consents for the vaccine instead of withdrawing would be acceptable for the gene test. That was last Friday.
This week, a clinical research nurse called and emailed me saying she would like to help me. I thought great, but after exchanging numerous emails and phone calls, I was referred to the same nurse, who first told me to withdraw from the vaccine trial., to confirm if I don’t have to withdraw! For three days I worked hard but I was making a circle and coming back to the starting point. It was discouraging and disappointing.

Big sigh ;-(

Then I started over; emailing to the director,” May I ask you the same question once again?’

A Story of Sara

Being weary, I remembered about Sarah, Abraham’s wife, in Genesis. She, who could not wait for the fulfilment of God’s prophecy that she would give a birth to a son, gave her slave Hagar to Abraham to have a child (Ishmael). Yet, eventually Sara became pregnant and indeed gave birth to Isaac. The tension and hostility grew in-between two mothers as well as two sons, and has continually grown between the offsprings of Ishmael, Muslims, and the offsprings of Isaac, Jews and Christians, even creating terrorists ISIS in this century. Because she was inpatient and acted on her own, the consequence was horrible. Maybe why I am in the maize without progress is that I am acting like Sarah instead of waiting for God opening the door…

Breakthrough

As I was writing so far, I noticed there was an email from Kaiser. I opened it….Yes! The answer was given!
The Kaiser doctor, who is in charge of the study accepted my request and allowed me to hold the consents for the vaccine. NCI will keep my medical information and my place in line so that I can go back to the vaccine trial if I am not qualified for the targeted drug trial at Kaiser.
Now I can turn in the consent forms for the gene test!

In the email from the Kaiser research director, she said,
“Your persistence paid off. So good for your Kathy, you keep on fighting. We all wish you well.”

Thank you Jesus! GOD IS GOOD ALL THE TIME!

Still In the Waters of Clinical Trial System

I thought I would be in the trial by now when I first decided to apply for a clinical trial in June. The reality is I am still waiting to be accepted for a trial. My summer was just researching and swimming in the waters of complicated clinical trial systems.

Last week when I was finally able to avoid withdrawing the consent from the vaccine trial, I thought now I was moving forward turning in another consent form to the gene test for the targeted drug. Yet this week I was told that the consent forms I turned in were invalid because I had to sign in front of a clinical nurse! Another big sigh.

Today finally my consent forms were accepted. I’m not sure when my cancer tissue will be sent to the lab for the gene test, but it will take about three weeks to get the result. If there is not enough tissue, I have to have a biopsy to collect the cancer tissue, so it will take longer. Then if the gene test result allows me to take the trial drug, I will take CT scans and labs as the physical screening, and then I have to hold off from chemo for four weeks to start the drug. So it will take at least two more months to be on the drug.

Then there was one more surprise waiting for me. When I asked how many people have been in the trial so far, the oncologist said, ” 200 people took the test and 5 were eligible. It’s like winning a lottery.”

5 out of 200!
I am so glad that I didn’t withdraw from the vaccine trial. In order to make a decision of a trial, I learned what I should ask for the first place. Actually I am wondering if I should go back to the vaccine trial now without waiting for the result to save the time. Readers, what do you think? I have to pray.

I Quit

I decided to quit the Ignyta trial, the targeted drug trial.  Since yesterday when I heard that the matching rate of the gene test was less than 3% (5 out of 200), I have prayed and pondered if I should stay on the course or change to the vaccine.  The reason why I chose the targeted drug over the vaccine was because I had read that the drug’s response rate was 75% once it matched.  Yet I didn’t know the matching rate was so little.

The only condition to try the gene test seems if the current regimen is working.  Yet unless I take a CT, which I don’t want, or maybe an x-ray, I’m not able to know it. If I go back to the vaccine trial, the next step is a physical screening (CTs and lab tests), but I don’t know how long I have to wait for that.  Do I want to waste three weeks in such a case?  No.  That is my conclusion.

I emailed my oncologist and the clinical study nurse to let them know that I want to cancel the consents.  I was going to email NCI to go back to the vaccine trial, but I thought I should wait for the oncologist’s reply just in case – to make sure if I am misunderstanding what she said yesterday.

Nothing is certain  and everything is a gamble.  Regardless of my choice, I may be facing the dead end.  Or, regardless of my choice, God can sustain my life if that is His Will.